Clean Utilities Engineer
What you will do in this Clean Utilities Engineer role:
- Act as Clean Utility Engineering Subject Matter Expert from the design phase to equipment handover.
- Review and approve process flow diagrams (PFDs), specifications, layouts and P&ID’s.
- SME in mechanical, electrical and pneumatic utility systems.
- Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
- Lead, promote, participate and supervise the implementation and maintenance of the relevant safety programs.
- Support clean utility equipment installation, integration and coordinate vendor supervision as required.
- Develop and modify procedures as needed to support the clean utility area.
- Review and approve process-related commissioning, qualification and validation protocols for completeness and accuracy. Execute protocols on a timely basis to meet the project schedule requirements.
- Participate in and lead clean utility project implementations.
- The leadership of clean utility and validation activities during the project life cycle.
- Investigate process exceptions or equipment malfunction incidents affecting the process.
- Liaise with internal/external engineering personnel and contract maintenance providers in maintaining, troubleshooting and installing/commissioning equipment.
- Support the production team, ensuring that utility equipment is maintained to ensure production schedules run efficiently.
- Present on clean utility area in regulatory inspections ensuring successful outcomes
- Cross-functional collaboration with QC Micro, Operations, QA and Engineering
What you will need in this clean utilities Engineer role:
- A relevant third level qualification in an engineering, science or technical discipline (Degree Level or Master’s preferable)
- At least six (5) years of total combined experience in Clean Utility / Equipment or Manufacturing Engineering in Pharma, Biotech or Medical Device Industry.
- Previous experience in manufacturing biotechnological drugs, parenteral drugs, solutions preparation, fill-finish, Lyophilisation, sterilisation operations preferable. Experience in clean utilities is essential.
- Knowledge of policies and regulatory requirements ensuring compliance with cGMP and ISO/FDA regulations.
If you are interested apply today by sending your CV to Ryant@sigmar.ie
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